Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
71257–71280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2003
HL888BM
K032837 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
HL888BA
K032839 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS,...
K032858 · DSI
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · CDZ
Diagnostic Products Corp.
Chemistry · 25d
Cleared Oct 10, 2003
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
K032924 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 18d
Cleared Oct 10, 2003
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · IYO
Accutome, Inc.
Radiology · 18d
Cleared Oct 10, 2003
BRM2 BRAIN MONITOR
K033010 · OLT
Brainz Instruments , Ltd.
Neurology · 14d
Cleared Oct 10, 2003
MODIFICATION TO HL168
K033043 · DXN
Health & Life Co., Ltd.
Cardiovascular · 11d
Cleared Oct 10, 2003
ORTHOPHOS XG DS/CEPH
K033073 · EHD
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Oct 10, 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K033151 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
K033152 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162 · JJY
Cliniqa Corporation
Chemistry · 10d
Cleared Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
K033168 · LNH
General Electric Co.
Radiology · 10d
Cleared Oct 09, 2003
VELOPEX AQUACUT FLUID ABRASION UNIT
K024105 · KOJ
Velopex International, Inc.
Dental · 300d
Cleared Oct 09, 2003
EM PROBE, EM PAD
K024361 · ILY
Em Probe, Inc.
Physical Medicine · 283d
Cleared Oct 09, 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 239d
Cleared Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · MBH
Zimmer, Inc.
Orthopedic · 189d
Cleared Oct 09, 2003
CYNOSURE SMART FILE ND:YAG LASERS
K031125 · GEX
Cynosure, Inc.
General & Plastic Surgery · 183d
Cleared Oct 09, 2003
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K031265 · MNH
Spine Next SA
Orthopedic · 171d
Cleared Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE...
K032138 · KLA
Medtronic Vascular
Gastroenterology & Urology · 90d
Cleared Oct 09, 2003
DESENS-IONOMER
K032175 · EMA
Milton Hodosh, M.D.
Dental · 85d
Cleared Oct 09, 2003
NBD DISPOSABLE RF CANNULAE
K032196 · GXI
New Business Development, LLC
Neurology · 83d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300 · MEH
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Oct 09, 2003
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
K032357 · GEX
Lumenis, Inc.
General & Plastic Surgery · 71d